Manufacturer Endo Pharmaceuticals has issued a voluntary recall of Edex (alprostadil), an injection used to treat male erectile dysfunction.
This is a class II recall, the most common type of recall, which means that there is a situation where the use of the recalled medication may cause temporary or medically reversible adverse health consequences, but the likelihood of serious adverse effects is small. For more information on the different types of recalls, see our overview here.
Who can recall a drug?
A manufacturer can voluntarily recall their medication, or the Food and Drug Administration (FDA) can request or require that a manufacturer recall a particular medication. In this case, the manufacturer has voluntarily recalled Edex, with the knowledge of the FDA.
Why was Edex recalled?
Endo Pharmaceuticals has voluntarily recalled one lot of Edex because of a defect in the crimp caps. This defect in the caps could lead to a loss of proper closure, compromising the sterility of the product. Improper sterility could lead to infection at the site of injection or in the blood stream.
However, at this time there have not been any adverse events reported to Endo Pharmaceuticals due to this recall.
Which products were recalled?
In this recall, only one lot was affected. The affected lot was distributed from December 13th, 2016 through February 13th, 2017 to wholesale distributers and retail pharmacies in the United States.
The recall only affects the 10 mcg 2-pack injection carton, lot #207386 (Exp 5/2019).
What should I do if I have the recalled Edex product?
If you have the recalled Edex product, immediately discontinue use of the product and contact Inmar at 1-844-529-1586 or Edex@inmar.com.
To find out more about the Edex recall, you can read the manufacturer’s press release here.
If you have concerns that your prescription may be affected, contact your doctor or pharmacist for more information.
Cough is one of the most common symptoms people schedule a visit with their doctor about. During cold and flu season, persistent dry cough fills the primary care doctors schedule. It’s just a cough, but it won’t go away . . . could it be lung cancer? Tuberculosis? Coworkers, friends and family will tell you “go see a doctor for that cough.”
So here’s what you need to know:
- What qualifies as a persistent dry cough? An annoying dry cough, where you aren’t coughing up much junk, that has been present for more than three weeks . Dry cough is often the symptom that hangs on after the rest of your respiratory symptoms have resolved.
- Cool fact: women tend to cough more than men due to a heightened cough reflex sensitivity.
What is causing your persistent dry cough?
- Post-infectious reactive airway disease. At this time of year, this is the most common cause of lingering dry cough. It occurs after an acute upper respiratory illness and though it may linger it will resolve without specific therapy. Airway inflammation after infection causes them to be hyperresponsive and twitchy, making you cough.
- Upper airway cough syndrome (used to be called post nasal drip). Hints that this may be the cause of your cough: the sensation of liquid dripping down the back of your throat, throat clearing, and nasal discharge. A course of an intranasal spray like Flonase (fluticasone) or Nasacort over the counter may help solve that.
- Cough variant asthma. The second leading cause of persistent cough in adults is called “cough-variant asthma.” Hints here: it may follow an upper respiratory infection, and worsen with exposure to cold or certain allergens (dust, certain fumes). If your doctor suspects this, an oral inhaler will be part of the solution.
- Reflux. Gastroesophageal reflux disease (GERD) is a common cause of persistent dry cough. Know that for many people, cough due to reflux will NOT come with heartburn or a sour taste in your mouth. A two week course of Prevacid, (pantoprazole), Prilosec (omeprazole), or Nexium (esomeprazole) may solve your cough if this is the cause.
- Medication side effect. ACE inhibitors like lisinopril, ramipril, or quinapril are well known culprits of a persistent dry cough. The cough will resolve within 1 – 4 days of stopping your medication if this is the cause.
Now, ask yourself these three questions:
- Am I a smoker now or was I in the past?
- Do I take an ACE inhibitor medication?
- Did my doctor do a chest x-ray and is it normal? (Any cough present more than 8 weeks should be evaluated with a chest x-ray).
If you’ve answered no to these questions, 99.4% of you have one of the above 5 causes of persistent cough—so no need to read any further.
What is NOT a likely cause of persistent dry cough?
Here are the dangerous things patients worry may be the cause of their cough . . . and why you probably don’t have them:
- Lung cancer. Lung cancer is the cause of chronic cough in less than 2 percent of the cases. Smoking history matters here and more so than cough—weight loss, shortness of breath, coughing up blood—those are serious warning signs of lung cancer.
- Pulmonary Embolism (PE). A clot in the deep veins of the leg that breaks off and lodges in your lungs, a PE, will cause shortness of breath, pain in the chest and difficulty breathing. Just a dry cough is very very unlikely to be a PE.
- Tuberculosis (TB). With TB infection of the lungs you will have a cough, but also night sweats, weight loss, low grade fevers, and you won’t feel good at all. Not just a dry cough.
Final note: if you have a cough along with fever, shortness of breath, chest pain, weakness, and/or nausea and vomiting, it is NOT a persistent dry cough. That’s a different story. See your primary care doctor if this is the case.
Many of you don’t want to rely solely on medications for heartburn and reflux symptoms. While proton pump inhibitors—omeprazole (Prilosec), pantoprazole (Protonix), esomeprazole (Nexium)—and H2 blockers—Zantac, Tagamet, Pepcid—do work, there may be downsides to long term use.
Lifestyle changes are a must: limit acidic foods, eat smaller meals, avoid late night eating, keep the head of your bed elevated—but is there anything else you can take for heartburn and reflux? Here are ten common complementary and alternative therapies used for heartburn and gastroesophageal reflux:
- Probiotic supplements. Probiotic supplements containing Lactobacillus acidophilus are commonly used for heartburn and reflux symptoms. Probiotics or “friendly” bacteria may help maintain a balance in the digestive system between good and harmful bacteria. Lactobacillus acidophilus and Bifidobacterium lactis have the best evidence in their favor so look for those ingredients in your probiotic supplement.
- Aloe vera. Evidence has shown that two tablespoons up to three times a day of both aloe vera juice and syrup may improve heartburn. In one study, the effectiveness of aloe vera was comparable to those of the standard drugs ranitidine and omeprazole in relation to most symptoms. Aloe vera is readily available and may provide a safe and effective treatment for reducing the symptoms of GERD. Worth a try.
- Probiotic drinks such as kefir and liquid yogurts. Examples are GoodBelly, Wallaby or Lifeway. While there are numerous studies on irritable bowel syndrome symptoms and probiotic drinks, none have focused exclusively on heartburn or reflux. Having said that, a daily serving of a probiotic drink may result in changes in gut bacteria and improve heartburn and reflux symptoms.
- Prebiotics. Many beneficial effects on the gut have been associated with prebiotic use. What is a prebiotic? Dietary prebiotics are carbs that cannot be digested by the body but are “food” for probiotics. Prebiotics induce favourable changes in the intestinal bacteria. Prebiotic fiber supplements and powders are available including fructooligosaccharides, such as inulin and galactooligosaccharides. Including prebiotics in your diet with bananas, onions, garlic, leeks, asparagus, artichokes, soybeans and whole-wheat foods is a must.
- Iberogast (STW-5) liquid. Easily available online or at Whole Foods, Iberogast has been shown to improve heartburn and reflux symptoms. Iberogast is an herbal preparation containing extracts from bitter candy tuft, chamomile flower, peppermint leaves, caraway fruit, licorice root, lemon balm leaves, angelica root, celandine herbs and milk thistle fruit (whew!). Folks taking it daily (20 drops a day) for 4 weeks were found to have significantly improved symptoms over those who did nothing.
- Lactaid or digestive enzyme. While there are studies using Lactaid in infants for colic symptoms, Lactase enzyme supplement has not been well studied for heartburn, constipation or reflux in “normal” subjects. Having said that, lactose in dairy products is maldigested by up to 70% of the world’s population– and many people may therefore suffer symptoms similar to irritable bowel syndrome (bloating, pain, abdominal distention). Worth a try.
- Papaya preparation (Caricol). Made from the pulp of tree ripened papaya, Caricol is used as a natural remedy in abnormal digestion in tropical and industrialized countries. Studies have revealed that giving people 20 milliliters (mL) of Caricol daily for 40 days resulted in improvement in constipation, bloating and heartburn. Also worth a try.
- Cranberry (Vaccinium macrocarpon). Preliminary research suggests cranberry juice may inhibit H. pylori growth in the stomach. H. Pylori is the bacteria that is a common cause of heartburn symptoms and peptic ulcer disease. Adding cranberry juice to a standard regimen against H Pylori resulted in higher success rates. So, for heartburn and reflux it may be worth a try.
- Sodium Bicarbonate. Sodium bicarbonate is baking soda. Alka Seltzer is a common over-the-counter example that helps neutralize stomach acid. Worth a shot for heartburn symptoms.
- Silicol gel. Silicol gel is a compound of silicon + oxygen. Used for skin, hair and nails, there is little scientific evidence on silicol gel and the gut, but people are still trying it for heartburn, bloating and abdominal cramping. Silicon bound to oxygen is water-soluble, absorbable, and may potentially have biological activity that helps the gut.
Efficacy and safety of Aloe vera syrup for the treatment of gastroesophageal reflux disease: a pilot randomized positive-controlled trial. Panahi, Yunes Y. Journal of traditional Chinese medicine 12/2015 Volume: 35 Issue: 6
A mixture of trans-galactooligosaccharides reduces markers of metabolic syndrome and modulates the fecal microbiota and immune function of overweight adults. J. Vulevic, A. Juric, G. Tzortzis, G.R. Gibson J Nutr, 143 (2013), pp. 324–331
Silicon: the health benefits of a metalloid. Martin, Keith R KR. Interrelations between Essential Metal Ions and Human Diseases
Redefining lactose as a conditional prebiotic. Szilagyi A1. Can J Gastroenterol. 2004 Mar;18(3):163-7.
A plant extract and its modified preparation in functional dyspepsia. Results of a double-blind placebo controlled comparative study. Madisch A1, Melderis H, Mayr G, Sassin I, Hotz J. Z Gastroenterol. 2001 Jul;39(7):511-7.
According to The American Diabetes Association, as of 2012, type 2 diabetes affected 29.1 million Americans, 9.3% of the population. Every year another 1.4 million Americans are diagnosed with type 2 diabetes, which can lead to live-threatening complications like high-blood pressure, kidney disease, high cholesterol, or loss of vision.
Recently, the FDA approved Qtern (dapagliflozin and saxagliptin), a new combination prescription medication for adults with type 2 diabetes.
What is Qtern indicated for?
Qtern is a once-daily combination medication used in conjunction with diet and exercise for blood sugar control in adults with type 2 diabetes. Qtern is specifically indicated for adults who have already been inadequately treated with Farxiga (dapagliflozin) or Onglyza (saxagliptin).
Qtern helps blood sugar control by targeting 2 different pathways- the liver and the kidneys. It may even help you lose weight.
What dosage and strength will Qtern be available in?
Qtern will be available as a fixed-dose combination 10mg/5mg tablet.
What side effects are associated with Qtern?
The most common side effects include:
- Upper respiratory tract infections
- Urinary tract infections
- Increased amount of fat in the blood
- Low blood sugar
When will Qtern be available?
Qtern was approved by the FDA on February 28th, 2017, but does not have an anticipated release date at this time. You can register for ongoing news, information, and updates related to Qtern here.
As of July 2016, Qtern was approved in all 28 European Union countries, including iceland, Liechtenstein and Norway and has been approved in the UK since January 2017.
For more information on Qtern, see the press announcement from the manufacturer AstraZeneca here.
Tetanus, diphtheria, and pertussis are 3 very serious diseases that can typically be prevented through vaccinations. Currently, there are two vaccinations approved for immunization against these three diseases: Boostrix and Adacel. These vaccines are called Tdap vaccinations which are combination vaccinations that protect against tetanus, diphtheria, and pertussis (hence the name Tdap)
But what is the difference between Boostrix and Adacel? And when should you get them?
First off, what are these diseases?
- Tetanus, also known as lockjaw, is a rare infection caused by bacteria. Tetanus can cause painful muscle tightening all over the body, including the head and neck. This tightening can make it difficult to swallow or breathe. People can get tetanus from getting pricked by a rusty nail or needle.
- Diphtheria is a rare infection spread from person-to-person through bacteria in respiratory secretions like coughing or sneezing. A diphtheria infection can cause a thick, gray coating to build up in the throat or nose, making it difficult to swallow or breathe.
- Pertussis, also known as whooping cough, is an infection spread from person-to-person through respiratory secretions such as coughing or sneezing. A pertussis infection can cause severe coughing spells which may make it difficult to breathe and can lead vomiting and disturbed sleep.
When should someone get a Tdap vaccination?
A person should typically receive their one-dose Tdap vaccination around the age of 11 or 12. Pregnant mothers should also receive a dose of Tdap to protect their newborn babies from pertussis. Additionally, some people may be given a dose of Tdap after a severe cut or burn to prevent a tetanus infection.
What is the difference between Boostrix and Adacel?
The biggest difference is the age that the vaccines are recommended for. While Adacel is indicated for patients 10-64 years old, Boostrix is indicated for patients 10 years of age and older. Currently, Boostrix is the only Tdap vaccine indicated in patients 65 years of age and older!
What Tdap vaccine should pregnant women receive?
First off, ask your doctor. The Centers for Disease Control and Prevention (CDC) and the Advisory Committee on Immunization Practices (ACIP) does not recommend one vaccine over the other.
However, according to the official manufacturer package insert, Boostrix is considered Category B, whereas Adacel is considered Category C. Category B vaccines have failed to demonstrate a risk to the fetus, whereas category C vaccines have shown a adverse effects on the fetus. These categories are based on animal studies as there have been no well-controlled studies done in pregnant women.
What is the difference between Tdap and DTaP?
You may have wondered if there is a difference between Tdap vaccinations and DTaP vaccinations, as they treat the same diseases. The difference is as follows:
- The DTaP vaccine is for infants and children to initially protect them against tetanus, diphtheria and pertussis. This vaccine is a 5 part series, and is given at 2 months, 4 months, 6 months, 15-18 months, and 4-6 years.
- The Tdap vaccine is for adolescents and adults, as young as age 10, as a booster to proved extra protection against tetanus, diphtheria and pertussis.
For more information on vaccinations, see the CDC’s vaccination schedule for children and adults here.